Episode 6 - Regulatory Science

Our guest this week is Dr. Joe Lennerz, Associate Chief of Pathology and the Medical Director of the Center for Integrated Diagnostics (CID) at Massachusetts General Hospital (MGH). He oversees all aspects of the clinical laboratory service that supports personalized medicine at MGH.

He was the principal investigator of the first FDA instrument precision study for the first whole slide scanning system.

We're talking about Regulatory matters in digital pathology, the various regulatory bodies at play and the alphabet soup of regulation such as CLIA, CAP , FDA, GDPR and so forth.

We'll discover what is the 21st Century Cures Act and how does it impact digital pathology? And many folks may be surprised to learn about new initiatives such as the Digital Health Center of Excellence at the FDA designed to spur innovation.

We’ll learn about the Alliance for Digital Pathology - A regulatory science initiative to harmonize and standardize digital pathology processes to speed up innovation to patients.

In the past, it's been tempting for many of us to think of regulation as a burden but is this mode of thinking outdated? By proactively forming partnerships with regulatory bodies, will we actually be able to spur innovation and advance the state of the Science?